Quality Management
You want to be certain that your clinical trial is in the best of hands. We have therefore set ourselves extremely high quality standards:
- Our Quality Management department is based in-house and functions independently of the study team.
- Our management system is based and certified per DIN EN ISO 9001 : 2000
- Its core task is the continuous improvement of processes in accordance with national and global quality standards.
- Our goal is to use “quality assurance in operation” to become Germany’s first choice for clinical trials.
What is meant by “quality assurance in operation”?
We use audits to constantly monitor our processes and performance.
Items checked:
- ICH GCP
- Regulatory requirements and norms
- Special arrangements with our customers
- Trial protocols
- SOPs
- ICH GMP
- Trial protocols audits
- Subject information/informed consent audits
- On-site study audits
- Report audits
- Investigator regulatory files audits
We routinely carry out the following internal audits:
- Quarterly system audits
- Service provider audits
- Process audits as required by Senior Management
All audit results are evaluated and any room for improvement is incorporated into our optimisation process. Constant optimisation is assured by implementing corrective and preventive actions. This, in turn, gives you the assurance that you are in best of hands.